NCT07384429Not yet recruitingPhase 4
Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease
Study for the Dual Orexin Receptor Antagonist Lemborexant in Improving Motor-Sleep Comorbidity in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
The aim of this study is to explore the effects of the dual orexin receptor antagonist Lemborexant on improving motor and sleep comorbidity in patients with Parkinson's disease. This study will provide clinical evidence for the application of dual orexin receptor antagonists in the treatment of Parkinson's Disease.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 26 Jan 2026
- Start date
- 19 Aug 2026
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- YangPan
- Diseases
- Parkinson disease
- NCT number
- NCT07384429
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 44
- From 19 Aug 2026 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 7\. Use of any orexin receptor related medication within the past 3 months.
- 8\. Previous history of cataplexy or known reduced orexin levels;
- 10\. Use of other sleep-promoting medications within the past 3 months.
Other illness
- 1\. History of or diagnosis with a severe psychiatric disorder, such as depression, anxiety disorders, schizophrenia spectrum disorders, or bipolar disorder;
- 2\. Presence of a clinically defined neurological disorder (assessed via self-report), including but not limited to: any condition potentially associated with increased intracranial pressure, space-occupying brain lesions, history of stroke, transient ischemic attack within the past 2 years, cerebral aneurysm, dementia, or multiple sclerosis;
- 3\. Severe cognitive impairment (Mini-Mental State Examination (MMSE) score below 24) or inability to complete questionnaires independently;
- 4\. Chronic obstructive pulmonary disease (COPD) or any lifelong history of sleep-related breathing disorders, such as sleep apnea;
Other
- 5\. Excessive daytime sleepiness, defined as self-reported daily daytime napping ≥ 1 hour per day on ≥ 3 days per week;
- 6\. Regular caffeine consumption;
- 9\. Inability to read or understand Chinese;
Who the study is looking for
- 1\. Aged 50 years or older;
- 2\. Diagnosed with idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease (2015), with a Hoehn \& Yahr stage of 1 to 4;
- 3\. Disease duration of ≥ 2 years since diagnosis, clinically stable, and able to comply with the research assessments and interventions;
- 4\. Diagnosis of insomnia disorder meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with an Insomnia Severity Index (ISI) score of ≥ 15;
- 5\. Stable medication regimen for at least 4 weeks prior to the study;
- 6\. Signed informed consent form, with the participant or their legal guardian able to understand and willing to participate in this study.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongnan Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.